| Primary Device ID | 07290016814361 |
| NIH Device Record Key | f8b58040-1aca-420b-bb40-20119e389695 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PURE Laser, System |
| Version Model Number | PURE Laser |
| Catalog Number | ND_PRD00456-00 |
| Company DUNS | 531958689 |
| Company Name | ENDYMED MEDICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com | |
| Phone | 1-855-363-9633 |
| support@endymed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016814361 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-27 |
| Device Publish Date | 2023-06-19 |
| 07290016814408 - EndyMed PRO MAX, System, 110V | 2024-05-24 The EndyMed PRO MAX System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- |
| 07290016814415 - endyMed PRO MAX, Intensif MAX Handpiece | 2024-05-24 The Intensif applicator is intended for use in dermatologic and general surgical procedure for electrocoagulation nd hemostasis |
| 07290016814422 - EndyMed PRO MAX, Small MAX Handpiece | 2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic |
| 07290016814439 - EndyMed PRO MAX, FSR MAX Handpiece | 2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic |
| 07290016814446 - EndyMed PRO MAX, iFine MAX Handpiece | 2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic |
| 07290016814453 - EndyMed PRO MAX,Shaper MAX Handpiece | 2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic |
| 07290016814460 - EndyMed PRO MAX,Mini Shaper MAX Handpiece | 2024-05-24 The handpiece is used as an accessory to EndyMed PRO MAX system, which is a noninvasive device intended for use in Dermatologi |
| 07290016814477 - EndyMed PRO MAX, Contour MAX Handpiece | 2024-05-24 The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator fo |